What's Happening?
The FDA has introduced the 'PreCheck' program aimed at strengthening domestic drug manufacturing by increasing regulatory predictability and facilitating the construction of pharmaceutical plants in the U.S. The program consists of a two-stage approach: facility readiness and application submission phases. This initiative follows President Trump's executive order to accelerate domestic drug manufacturing development. The FDA is seeking public comments on regulatory hurdles and will hold a hybrid public meeting on September 30 to present a draft framework for onshoring drug and biologic products.
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Why It's Important?
The 'PreCheck' program is significant as it addresses the reliance on overseas manufacturing for pharmaceuticals distributed in the U.S., with over half currently produced abroad. By enhancing domestic manufacturing capabilities, the program aims to improve the U.S.'s pharmaceutical supply chain resilience and reduce dependency on foreign manufacturers. This initiative could lead to increased investment in U.S. drug manufacturing facilities, potentially boosting local economies and job creation in the sector.
What's Next?
The FDA will hold a public meeting to discuss the draft framework for facilitating the onshoring of drug manufacturing. Stakeholders, including pharmaceutical companies and regulatory bodies, are expected to provide input on the proposed changes. The program's success will depend on overcoming regulatory challenges and attracting investment in domestic facilities.
